Ventricular assist devices, known as VADs, often include an implantable blood pump and are used for both short-term (i.e., days, months) and long-term applications (i.e., years or a lifetime) where a patient's heart is incapable of providing adequate circulation, commonly referred to as heart failure or congestive heart failure. According to the American Heart Association, more than five million Americans are living with heart failure, with about 670,000 new cases diagnosed every year. People with heart failure often have shortness of breath and fatigue. Years of living with blocked arteries and/or high blood pressure can leave a heart too weak to pump enough blood to the body. As symptoms worsen, advanced heart failure develops.
A patient suffering from heart failure may use a VAD while awaiting a heart transplant or as a long term destination therapy. A patient may also use a VAD while recovering from heart surgery. Thus, a VAD can supplement a weak heart (i.e., partial support) or can effectively replace the natural heart's function.
A VAD system often includes a controller or patient interface module to control operation of the VAD. The patient interface module can provide operational feedback to the user such as system status indications (e.g., battery charge status) and system alarms (e.g., for system faults).
A fault in a patient interface module may sometimes require replacing the faulty patient interface module with another (typically identical) patient interface module. When the fault is critical or otherwise appears to require urgent replacement, the replacement may need to be performed by the patient or a caregiver, as opposed to a perceived non-critical fault when the replacement can be delayed until the patient visits a clinic. Replacing a patient interface module, whether the fault is critical or not, can be a life-and-death situation for the patient. The patient/caregiver typically understands what is at stake and perceives the replacement as a very high-stress operation. The combination of high stress and a very rare situation (for which training, if any, may have been conducted a long time ago) can lead to user error during replacement, resulting in adverse events, including even possible patient death by inadvertent disconnection of modules which supply power to the pump.
Some progress has been made in reducing adverse consequences associated with patient replacement of a faulty patient interface module. For example, patient interface module connectors can include clearly marked labels that indicate how to make the connection. Ideally, a VAD system is configured to minimize faults requiring replacement of a faulty patient interface module. Conventional mechanical circulatory support (MCS) systems, however, are still configured to allow only one controller supplying power to be connected to the VAD at a time. Thus, replacement of the controller interface module requires following carefully designed steps to ensure that no power is lost at any point in the replacement process.
While some progress has been made, existing approaches have some undesirable attributes. Typical approaches focus on patient training, designing the interface modules to prohibit improper connections, and visual markings and cues. None of these fully address the underlying problem. For example, even when clearly marked, patient interface module connectors are typically difficult to connect, partly due to construction (patient interface module connectors need to be difficult to accidentally disconnect, large enough for limited dexterity patients to handle, etc.) and partly due to lack of recent training of the patient in replacing a faulty patient interface module. Patient training on how to replace a faulty patient interface module is typically infrequent so as to occur long before a “live” replacement situation. More so, consistent training cannot adequately prepare all patients for performing the operations in a stressful emergency situation. Even if the occurrence of faults requiring the replacement of a patient interface module are minimized, the act of replacing a faulty patient interface module is not any easier for the patient to accomplish and in fact may be harder due to the reduced resulting patient experience with replacing a faulty patient interface module. Accordingly, improved approaches and systems for replacing a faulty patient interface module would be beneficial.